NCT00918411已完成4 期
Post-marketing Clinical Study of Ramosetron Hydrochloride (Irribow Tablets) - A Preliminary Study to Evaluate the Co-primary Endpoint in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 主要终点
- IBS severity index (Japanese version)
研究概览
简要总结
The purpose of this study is to explore and examine endpoints that allow evaluation of the "clinically significant improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable bowel syndrome (IBS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the Rome III Diagnostic Criteria
- •Loose (mushy) or watery stools within the last 3 months
排除标准
- •Patients having hyperthyroidism or hypothyroidism
研究组 & 干预措施
Ramosetron group
Experimental
oral
干预措施: Ramosetron (Drug)
Placebo group
Placebo Comparator
oral
干预措施: Placebo (Drug)
结局指标
主要结局
IBS severity index (Japanese version)
时间窗: 12 weeks
次要结局
- Patient reported global assessment of relief of IBS symptoms(12 weeks)
- Patient reported assessment of improvement of abdominal bowel habits(12 weeks)
- Patient reported assessment of relief of abdominal discomfort and/or pain(12 weeks)
研究者
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